IVD medical device,

The sampling kit consists of the labelled urea, which is a drug a sampling straw, which is a device and a sample container, which would be considered an in-vitro diagnostic (IVD) medical device under EU definitions. Other examples of diagnostic drug products used in conjunction with medical devices include dyes administered to visualise blocked veins and arteries. 

Studies to investigate the safety and effectiveness of In Vitro Diagnostic (IVD) medical devices under intended use conditions are conducted as performance evaluations. They are considered to present less risk than clinical investigations since, by their nature, studies involving IVDs cannot have any direct impact on the health and safety of trial subjects. 

The Safe Medical Devices Act of 1990, a major revision to the 1976 amendments, among other revised requirements provided two major mechanisms for bringing an IVD medical device to market premarket notification and premarket approval. The act is administered by the FDA s Center for Devices and Radiological Health, of which the Division of Clinical Laboratory Devices (DCLD) is a part. The premarket notification process is used for devices that can be classified... 

Global Harmonization Task Force. Definition of the terms Medical Device and In Vitro Diagnostic (IVD) Medical Device . Study Group 1 of the Global Harmonization Task Force 2012. 

Ultrasound and X-ray equipment are examples of diagnostic medical devices. In-vitro medical devices are distinguished from other diagnostic medical devices, in that a specimen must first of all be removed from the donor. A device worn by a diabetic that continually monitors their glucose via a non-invasive method (near-infra-red energy emissions) would be just regulated as a medical device, whereas a glucosemonitoring device that used a lancet to obtain a blood sample would be an IVD. 

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

Class 1 medical devices, which include some simple IVDs, are usually exempt from the premarket section 510(k) application process, and their manufacturers are only required to register and list, follow good manufacturing practices, and report device failures. As experience develops with a given medical device it can be reclassified downward from class 3 to class 2 and eventually to class 1. 

Under the Medical Device Amendments of 1976, the FDA is responsible for premarket evaluation of all laboratory testing devices (in vitro diagnostics) intended to be commercially marketed in the United States. There are two major pathways for introducing a medical device into the marketplace the premarket notification [510(k) clearance] and the premarket approval (PMA). The purpose of the 510(k) is to establish that a device is substantially equivalent (SE) to a legally marketed (predicate) device. The purpose of the PMA evaluation process is to establish the intrinsic safety and effectiveness of a new device. Unless specifically exempt, a sponsor must have an approved PMA or cleared premarket notification [510(k)] by the FDA before a device may be legally marketed for IVD use (Fig. 1). 

The basic structure, concepts and terminology of the three Directives on AlMDs, MDs and 1 VDs are identical the differences that exist among them arise out of the different nature of these products. The following discussion will therefore focus on the medical devices directive (MDD), since this is the central Directive and covers most products. Short sections follow on AlMDs and IVDs. Detailed analysis of the relevant provisions would fill a large book what is intended here is to highlight the important aspects which should be considered. 

In vitro diagnostic (IVD) products These are medical devices which analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease. Classification for these devices can be found under 21 CER 862, 21 CER 86 , and 21 CER 866. 

Many organizations have been involved in developing a traceable accuracy base for analytes of clinical interest (see Chapter 14). A driver for current efforts to develop such a base is the European Directive 98/79/EC on in vitro diagnostic medical devices (www.ce-mark.com/ivd.pdf), which requires that The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of a higher order. ... 

Another important document published by the EU on discrimination between MDs, drugs, cosmetics, accessories, and in vitro diagnostics (IVDs) is the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices [29], updated annually (Rev. 1.17 as of September 2015). 

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